EUCTR2021-006088-61-Outside-EU/EEA进行中（未招募）1 期
An Open-Label, Multi-Center, Single-Dose Study to Assess the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Nasal Glucagon in Pediatric Patients with Type 1 Diabetes Aged 1 to <4 years - A Study to Assess Nasal Glucagon in Pediatric Patients with Type 1 Diabetes aged 1 to <4 years
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Have a Type 1 Diabetes diagnosis for at least 6 months
- •Have been receiving insulin therapy via multiple daily injections or using an insulin pump and have been stable for at least 3 months prior to screening
- •Have a HbA1c level of = 9.5% at screening
- •Have sufficient venous access for collection of blood samples
- •Have good general health, apart from their Type 1 diabetes, with no prior history of choanal atresia, nasal/pharyngeal blockage or nasal anomaly
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 6
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Have a presence or history of glucagon hypersensitivity
- •Have a history of pheochromocytoma
- •Have a history of epilepsy or seizure disorder
- •Have 1 or more congenital anomalies to the anatomy of the nose, or require changes to the anatomy of the nose
- •Are using closed-loop insulin therapy, unless such a device is set to 'open loop/manual' mode on the day of the dosing visit
- •Have an episode of severe hypoglycemia or have had glucagon administered, during the 3 months prior to the screening visit and no severe hypoglycemia between the screening and dosing visit
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